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A Study in Leukemia Patients With Karonudib
Sponsor: Thomas Helleday Foundation
Summary
The primary objective of this study is to determine safety and tolerability of Karonudib for the treatment of hematological malignancies. Secondary objectives are to determine a recommended RP2D and schedule for further development of Karonudib, to determine the pharmacokinetics of Karonudib, to look for evidence of treatment efficacy. Overall survival will also be recorded.
Official title: A Phase 1 Study in Patients With Hematological Malignancies to Evaluate Safety, Tolerability and Efficacy of Karonudib
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
9
Start Date
2019-12-03
Completion Date
2026-12-30
Last Updated
2025-12-19
Healthy Volunteers
No
Conditions
Interventions
Karonudib
First part of the study - four different dose cohorts Extension part of the study - karonudib BID (twice a week) and Idarubicin days 1-3.
Locations (6)
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet Copenhagen University Hospital
Copenhagen, Denmark
University Clinical Center Belgrade
Belgrade, Serbia
University Clinical Center Kragujevac
Kragujevac, Serbia
Karolinska University Hospital
Huddinge, Sweden
Örebro University Hospital
Örebro, Sweden